Registration Dossier

Administrative data

Description of key information

skin 
in vivo, rabbit, 4 h, semiocclusive: not irritant (GLP, OECD 404; Langobardi 2003)
eye
in vivo, rabbit: not irritant (GLP, OECD 405; Langobardi 2003)

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Skin

Skin corrosion and skin irritation was assessed in a GLP compliant study according to OECD test guideline 404 (Longobardi, 2003). Hexaoxatricosane was applied topically to three New Zealand White rabbits for 4 hours under semiocclusive conditions. Skin changes were scored at 1, 24, 48 and 72 hours after application according to the Draize scoring system. No topical reactions was observed 24, 48, and 72 hours after application of the test substance in any of the tested rabbits. The individual mean score (24 to 72 hours) in each of the three rabbits was 0.0 for both, edema and erythema.

In addition, topical exposure of 6 New Zealand Albino rabbits to hexaoxatricosane for 4 hours under occlusive conditions did not cause any skin reactions as well (Kuklinski et al., 1991).  

 

Eye

The potential of hexaoxatricosane to cause serious eye damage and eye irriation was assessed in an GLP compliant study according to OECD test guideline study 405 (Longobardi, 2003). When applied into the conjunctival sac of one eye of 3 New Zealand White rabbits a slight irritant effect was observed 1 hour after instillation. This effects was quickly reversible so that no eye irritating effect was observed at the 24 , 48, and 72 hour readings time points in all three tested animals.

No human information is available on the corrosivity and irritation of hexaoxatricosane.

Justification for classification or non-classification

Based on the available data on the corrosivity and irritation of hexaoxatricosane no classification is warranted according to the criteria of both, 67/548/EEC and CLP regulation (EC) 1272/2008.